A Biomarker for Cognitive Fatigue Using Functional Imaging in MS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Brain activation (BOLD signal)
Study Overview
Brief Summary
The purpose of this research study is to investigate the effectiveness of MS Disease modifying medications on cognitive fatigue in persons with relapsing remitting multiple sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.
Detailed Description
The researchers aim is to investigate the effects of disease modifying treatments on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with Multiple Sclerosis (MS). The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task, and also on how cognitive fatigue changes as a function of duration of treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 18-
- •Relapsing remitting multiple sclerosis
- •Been newly prescribed a new disease modifying medication for MS (either Ocrevus or Copaxone)
- •or healthy volunteer who can speak English fluently.
Exclusion Criteria
- •History of head injury, stroke, seizures, or any other significant neurological event other than MS
- •Flare up of MS symptoms within the past month.
- •History of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder.
- •Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids [cochlear implants]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
- •left handed.
- •Not able to have an MRI
Arms & Interventions
Multiple Sclerosis group 2
Individuals with Multiple Sclerosis who are going to be starting Copaxone as determined by Neurologist as part of clinical care.
Healthy Controls
Healthy individuals who are age, gender and education matched to the other groups.
Multiple Sclerosis group 1
Individuals with Multiple Sclerosis who are going to be starting Ocrevus as determined by Neurologist as part of clinical care.
Intervention: Ocrevus (Drug)
Outcomes
Primary Outcomes
Brain activation (BOLD signal)
Time Frame: Measured for change at 3 time points (before, six months and 12 months after intervention)
A change in brain activation as measured with functional magnetic resonance imaging through blood oxygen level dependent signal will be measured in association with cognitive fatigue (as measured by the Visual Analogue scale during performance of the modified Symbol Digit Modality and Modified Fatigue Impact Scale).
Secondary Outcomes
- Fatigue onset(Measured for change at 3 time points for change (before, six months and 12 months after intervention))
Investigators
John DeLuca
Senior Vice President for Research
Kessler Foundation